Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

May 18, 2020 updated by: Maciej Kaszyński, Medical University of Warsaw

Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.

Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain in children is still one of the most under diagnosed and under treated medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility. Untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. Postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. Growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. The studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and facilitates pain management. As such lidocaine infusion has been included in postoperative pain management guidelines for adults. Studies on children population have promising results but high quality randomized controlled trials are still missing.

The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-091
        • University Clinic Centre of Medical University of Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18 months and 18 year-old
  2. Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E
  3. Patients undergoing laparoscopic appendectomy

Exclusion Criteria:

  1. Allergy to local anesthetics or contraindication to use of lidocaine
  2. Patients with American Society of Anaesthesiologists physical status (ASA) IV or more.
  3. Severe cardiovascular disease
  4. Preoperative bradycardia
  5. Preoperative atrioventricular block
  6. Renal failure
  7. Chronic treatment with analgesics
  8. Parents' refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A - lidocaine group
Group A: children receiving standard general anesthesia with intravenous lidocaine infusion 1,5 mg/kg for 5 minutes before induction of anesthesia. After 5 minutes, lidocaine infusion continued at rate of 1.5 mg/kg/h during operation, and discontinued before move the patients to PACU.
Drug: Lidocaine
Lidocaine infusion during surgery
Other Names:
  • Intravenous lidocaine infusion
NO_INTERVENTION: Group B - control group
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 24 hours after surgery
Total nalbuphine requirement in milligrams during the first 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption
Time Frame: Intraoperative - from induction of anesthesia to extubation
Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Intraoperative - from induction of anesthesia to extubation
Intraoperative volatile anesthetic consumption
Time Frame: Intraoperative - from induction of anesthesia to extubation
Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Intraoperative - from induction of anesthesia to extubation
Time to first perception of significant pain
Time Frame: 24 hours after surgery
Time to first dose of nalbuphine - pain score > 3 points. Assessing Face - Legs - Activity - Crying - Consolability Scale/Numerical Rating Scale/Visual Analog Pain Scale depending on participant's age.
24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: 24 hours after surgery
Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr
24 hours after surgery
Side effects of lidocaine will be documented
Time Frame: 24 hours after surgery
Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2019

Primary Completion (ACTUAL)

January 15, 2020

Study Completion (ACTUAL)

January 17, 2020

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (ACTUAL)

March 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lido01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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